Back to resultsElectronic Warning System for Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Electronic warning alert
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Prevention, Anticoagulation, Electronic warning system
Eligibility Criteria
Inclusion Criteria:
- All in-patients with atrial fibrillation
Exclusion Criteria:
- Ongoing anticoagulant therapy
Sites / Locations
- Swiss Cardiovascular Center, Inselspital, University of Bern
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Electronic alert
No electronic alert
Arm Description
Physicians, whose patients with atrial fibrillation do not receive stroke preventive measures, will receive an electronic warning alert.
Physicians, whose patients with atrial fibrillation do not receive stroke preventive measures, will receive no electronic warning alert.
Outcomes
Primary Outcome Measures
Rate of initiation of adequate measures to prevent stroke (oral anticoagulant prescription) by physician in charge
Reviewed from discharge letter
Secondary Outcome Measures
Use of the CHA2DS2VASc score calculation tool by the physician in charge
Rate of correct evaluation of the CHA2DS2VASC Score through the calculation tool by physician in charge
Full Information
NCT ID
NCT02455102
First Posted
May 6, 2015
Last Updated
December 21, 2015
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT02455102
Brief Title
Electronic Warning System for Atrial Fibrillation
Official Title
Electronic Warning System to Improve Stroke Prevention in Atrial Fibrillation - A Quality Improvement Initiative at the University Hospital Bern
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this randomized controlled study is to evaluate whether a newly designed electronic warning system will increase the initiation rate of adequate stroke preventive measures in patients with atrial fibrillation.
Detailed Description
A large proportion of patients with atrial fibrillation do not receive stroke prevention therapy in line with the guidelines, in spite of the presence of an increased risk of stroke. It will be investigated whether an electronic alert to physicians, whose patients with atrial fibrillation do not receive stroke preventive measures, will increase the rate of adequate stroke preventive measures as compared to a control group of patients without an electronic alert. The electronic alerts will be sent if patients with atrial fibrillation but without adequate stroke preventive measures receive in-patient treatment at the University Hospital Bern. The electronic alert system includes a feature that helps the physicians in charge to evaluate the CHA2DS2VASC Score. At the end of the hospital stay medical discharge letters will be reviewed for initiation of adequate stroke preventive measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Prevention, Anticoagulation, Electronic warning system
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1707 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electronic alert
Arm Type
Active Comparator
Arm Description
Physicians, whose patients with atrial fibrillation do not receive stroke preventive measures, will receive an electronic warning alert.
Arm Title
No electronic alert
Arm Type
No Intervention
Arm Description
Physicians, whose patients with atrial fibrillation do not receive stroke preventive measures, will receive no electronic warning alert.
Intervention Type
Other
Intervention Name(s)
Electronic warning alert
Intervention Description
A newly-installed warning system for stroke prevention in atrial fibrillation.
Primary Outcome Measure Information:
Title
Rate of initiation of adequate measures to prevent stroke (oral anticoagulant prescription) by physician in charge
Description
Reviewed from discharge letter
Time Frame
End of hospital stay (expected average duration of 1 week)
Secondary Outcome Measure Information:
Title
Use of the CHA2DS2VASc score calculation tool by the physician in charge
Time Frame
During hospital stay (expected average duration of 1 week)
Title
Rate of correct evaluation of the CHA2DS2VASC Score through the calculation tool by physician in charge
Time Frame
End of hospital stay (expected average duration of 1 week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All in-patients with atrial fibrillation
Exclusion Criteria:
Ongoing anticoagulant therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nils Kucher, Prof. M.D.
Organizational Affiliation
Department of Angiology, Swiss Cardiovascular Center, University of Berne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swiss Cardiovascular Center, Inselspital, University of Bern
City
Bern
ZIP/Postal Code
3012
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
27451467
Citation
Silbernagel G, Spirk D, Hager A, Baumgartner I, Kucher N. Electronic Alert System for Improving Stroke Prevention Among Hospitalized Oral-Anticoagulation-Naive Patients With Atrial Fibrillation: A Randomized Trial. J Am Heart Assoc. 2016 Jul 22;5(7):e003776. doi: 10.1161/JAHA.116.003776.
Results Reference
derived
Learn more about this trial
Electronic Warning System for Atrial Fibrillation
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